Ultra-trace determination of oxaliplatin impurities by sweeping-MEKC-ICP-MS

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989592%3A15310%2F22%3A73615369" target="_blank" >RIV/61989592:15310/22:73615369 - isvavai.cz</a>

Result on the web

<a href="https://www.sciencedirect.com/science/article/pii/S0026265X21010535" target="_blank" >https://www.sciencedirect.com/science/article/pii/S0026265X21010535</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1016/j.microc.2021.106967" target="_blank" >10.1016/j.microc.2021.106967</a>

Result language

angličtina

Original language name

Ultra-trace determination of oxaliplatin impurities by sweeping-MEKC-ICP-MS

Original language description

Oxaliplatin represents a platinum-based cancerostatic drug that is widely used for the treatment of various types of cancer. There are two main platinum-containing impurities, impurity B and C, that can be formed as side products at very low concentrations. Their effect on biological systems can be like the oxaliplatin itself; however, this has not been fully investigated since there is a lack of methods for their determination in ultralow con-centrations. In our work, we present a method for ultra-trace determination of oxaliplatin impurities B and C, and oxaliplatin itself, using online sweeping preconcentration micellar electrokinetic chromatography coupled with inductively coupled plasma mass spectrometry (MEKC-ICP-MS). This is the first application of online pre-concentration with MEKC-ICP-MS to improve the detection limits of analytes. Under the optimal conditions, 25 mM sodium phosphate buffer at pH 2.15 with 175 mM SDS, and an injection time of 90 s at 50 mbar, baseline separation of all components within 6 min was achieved. The sweeping-MEKC-ICP-MS method was fully vali-dated in terms of linearity, limits of detection and quantification, trueness, precision, and reproducibility of migration times. Limits of detection of 2, 1, and 3 ng mL(-1) for impurity B, impurity C, and oxaliplatin, respectively, were obtained, which are 3,500-, 1,700-, and 2,100-fold lower than those for a MEKC-UV method also developed and validated as a part of this work. It also represents the detection of 98 femtograms of the impurity C (or 227 attomol of Pt) per injection. The sweeping-MEKC-ICP-MS method further benefits from a wide dynamic range up to six orders of magnitude (0.01-1,000 mu g mL(-1) for oxaliplatin) with coefficients of deter-mination greater than 0.9989. ICP-MS provides characteristic element/isotope-specific and structure-independent detection. ICP-MS helped identify the co-separated impurity B counter-ion that can be wrongly assigned as the platinum-based impurity B using standard UV detection. Finally, the validated sweeping-MEKC-ICP-MS method was applied to the analysis of oxaliplatin samples with variable impurities concentrations (0.06-1.0%). The trueness and precision ranged between 76 and 115% and 2-19%, respectively. This method allows the accurate determination of oxaliplatin impurities from 0.0003% levels; therefore, it could be used in routine pharmaceutical laboratories for quality control purposes.

Czech name

—

Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

10406 - Analytical chemistry

Project

<a href="/en/project/GA19-23033S" target="_blank" >GA19-23033S: Improving sensitivity in chiral separations using capillary electrophoresis connected with ESI-MS or ICP-MS</a><br>

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year

2022

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Name of the periodical

MICROCHEMICAL JOURNAL

ISSN

0026-265X

e-ISSN

1095-9149

Volume of the periodical

172

Issue of the periodical within the volume

JAN

Country of publishing house

NL - THE KINGDOM OF THE NETHERLANDS

Number of pages

6

Pages from-to

"106967-1"-"106967-6"

UT code for WoS article

000719818300010

EID of the result in the Scopus database

2-s2.0-85118726144